July 16, 2013 - Tata Memorial Hospital

Dear Dr. D'cruz:

Thank you for your February 27, 2013 report in response to our January 17, 2013
letter to Tata Memorial Hospital (TMH) regarding determinations of noncompliance with Department of Health and Human Services (HHS) regulations for the protection of human research subjects (45 CFR part 46). In our July 5, 2012 letter, we made the following determinations, among others:

A. Determinations regarding the above-referenced research

We determined that minutes of IRB meetings do not exist (or were not provided to our office upon request) for numerous meetings; and that minutes of IRB meetings that were provided to us are not in sufficient detail to show the vote on actions taken by the IRB including the number of members voting for, against, and abstaining, as required by HHS regulations at 45 CFR 46.115(a)(2).  

Corrective Action:  We acknowledge that the TMH has developed written IRB standard operating procedures (SOPs) that describe how votes on the actions taken by the IRB are recorded, when the IRBs review research involving HHS support.  Please note that the HHS protection of human subjects regulations require that votes be recorded to include the number of members voting for, against, and abstaining.  We also acknowledge that TMH has developed written procedures for research involving HHS support for ensuring prompt reporting to appropriate institutional officials, any U.S. Federal Department or Agency head, and OHRP of (a) any unanticipated problems involving risks to subjects or others; (b) any serious or continuing noncompliance with 45 CFR Part 46 or the requirements or determinations of the IRB; and (c) any suspension or termination of IRB approval.  

We determine that the corrective actions adequately address the determinations.  At this time, there should be no need for further involvement by our office in this matter.  Please notify us if you identify new information which might alter this determination.

We appreciate the continued commitment of your institution to the protection of human research subjects.  Please do not hesitate to contact me should you have any questions.

Sincerely,

Kristina C. Borror, Ph.D.
Director, Division of Compliance Oversight

cc:
Dr. Rajendra A. Badwe, Director, Tata Memorial Centre
Dr. Madhuri Gore, Chairperson, Human Ethics Committee-I, Tata Memorial Hospital
Dr. Urmila Thatte, Chairperson, Human Ethics Committee-II, Tata Memorial Hospital
Dr. Surendra Srinivas Shastri, Tata Memorial Hospital

Dr. Margaret Hamburg, Commissioner, Food and Drug Administration (FDA)
Dr. Joanne Less, FDA
Dr. Sherry Mills, National Institutes of Health (NIH)
Mr. Joseph Ellis, NIH
Dr. Harold Varmus, Director, National Cancer Institute, NIH